Exclusivity Parking Still Possible Under Teva Ruling

Law360 (April 4, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration's finding this year that Teva Parenteral Medicines Inc. would not have to renounce its exclusivity window for its generic granisetron cast light on certain holes in the Medicare Modernization Act of 2003 that could allow generic-drug makers to continue “parking” their exclusivity past the forfeiture deadline the legislation attempted to set.

By stating that Teva had not forfeited its exclusivity period for the generic version of Hoffmann-La Roche Inc.'s Kytril, which treats nausea from chemotherapy, the FDA letter ruling in...
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